COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name: Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety
CAS number: -
EC number: -

The substances are proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Toxic for reproduction (Article 57c)

Disclaimer: Comments provided during the consultation are made available as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of substances of very high concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions.

PART I: Comments and responses to comments on the SVHC proposal and its justification

Table 1. General comments on the SVHC proposal
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5430
2020/10/02	Kaneka Belgium N.V.,
Company,
Belgium	Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business :  DOTL is one of the approved catalysts for Blue Angel certification (German Ecolabel) and the only catalyst on the approval list which cures silane terminated polyethers.  There are no other alternative approved catalyst available and therefore it would be near impossible to certify adhesives and sealants based on silane terminated polyethers . As such this technology will be blocked for current users with a significant volume loss in consequence.

	Thank you for your comment.

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process. 	
5443
2020/10/15	FEICA,
Industry or trade association,
Belgium	Attachment: 5443_DOTL public consultation SVHC 201016.pdf
	Thank you for your comment.

Please find the answer to your comment in the table 3.	
5444
2020/10/15	Padanaplast S.r.l,
Company,
Italy	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL), CAS number [3648-18-8], EC / List N°. 222-883-3, as a Substance of Very High Concern (SVHC) under REACH.
Padanaplast S.r.l. is one of the worldwide leader in production and commercialization of silane-crosslinkable polymeric compounds for application in electric cable and plastic pipe industries. Accordingly with this technology, known as Sioplas® method, DOTL is used as catalytic agent for the crosslinking reaction, by which the polymer contained in the compound passes from a thermoplastic to a thermosetting state with great enhancement of its performances, particularly regarding, maximum temperature of use, stability at high temperature, mechanical properties and chemical resistance.
This technology is widely consolidated in Wire and Cable and Plastic Pipe industry thanks to its main peculiarity, that is the possibility to get the crosslinking without use of expensive and energy consuming post treatment. Indeed, with Sioplas® technology crosslinking can be achieved simply exposing the finished product (cable or pipe) to the ambient humidity. On contrary, competitor technologies requires special equipment to get the crosslinking, that are:
- peroxide crosslinking: requires treatment in high pressure vapor for a certain permanence time; high cost of investment for the plant, maintenance and energy during plant running required
- electron beam crosslinking: requires special generators of a high energy electron beam; high cost of investment for the plant, for the shielding and safety devices, maintenance and energy during plant running required
In case of application in Wire and Cable Industry, the Sioplas® method is particularly used in “green” Flame retardant materials, that don’t contain halogens and other substances that drive to acid and toxic emissions and dark smokes in case of fire.
The role of DOTL in this regard is as catalytic agent to promote the crosslinking, that other way would not proceed at an acceptable rate in industrial conditions. To implement this function, DOTL is embedded in a polymer matrix in dilute form; its concentration in the finished goods may range from 0.01 to 0.3 %.

Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business:
For Padanaplast the market for this type of materials is worldwide, nevertheless competitors are producing similar grades also in non-EU areas.
For Padanaplast consequences for a broad ban of DOTL would mean a big drop in revenues due to loss of performances, business and no possibility to compete with non-EU competitors. A contingency plan to look for possible alternatives and/or different markets and applications would require very long time (5-10 years at least) to redefine our business market and model, reformulate, get the approvals from customers and ramp up to the current level of revenues.
Valuable economic loss would come also from the approval of new products both for Padanaplast and for our customers. We cannot give a precise figure but the order is 500 k€ to 1M€.
At the time being no valid alternatives to DOTL have been yet found. The issue is only technical, since at the current state of know-how other candidates are too far from the performances and efficiency of DOTL.
(see more details on business at the attached confidential file)

Potential for human health exposure from our uses is as follows:
In Padanaplast industrial process pure DOTL is embedded in a polymer matrix. A closed and continuous process is used with occasional controlled exposure (PROC 2).
The worker is exposed only when the drum (200Kg) of DOTL is opened to insert a suction pipe to convey the product to the dosing system that is directly connected to the automatic and closed injection system (PROC 8b).  Exposition time for one worker for 8 working hours is calculated to be less than 15 min, operator/source distance less than 1 meter but all the operations are made under fume hood (EN UNI 14175).
	Thank you for your comment.

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
		Confidential attachment removed		
5445
2020/10/16	ReachCentrum SA acting on behalf of the interested Members of the OrganoTin REACH Consortium,
Company,
Belgium		Thank you for your comments and the information provided. 

The current SVHC proposal is based on the existing Annex VI entry of the CLP Regulation including the two names: dioctyltin dilaurate and stannane, dioctyl-, bis(coco acyloxy) derivs.
 
As noted on the ECHA website (https://echa.europa.eu/consultations-in-the-authorisation-process) harmonised classification and labelling cannot be challenged in the context of the SVHC process. COMMISSION DELEGATED REGULATION (EU) 2020/1182 was published in the Official Journal on 11 August 2020, entered into force 20 days later and is binding in its entirety and directly applicable in all Member States. Should new data become available that may challenge the current classification, this should be brought up in the context of the harmonised classification and labelling (CLH) process.
 
The Annex XV dossier for the SVHC entry proposal provides an explanation in relation to the identifiers used to describe the scope of the entry:
 
According to the REACH lead registrant of dioctyltin dilaurate, the substance currently on the European market is the UVCB substance stannane, dioctyl-, bis(coco acyloxy) derivs. although registered under the mono-constituent substance dioctyltin dilaurate (personal communication, January 2016).
 
Such information was also included in the CLH proposal that included both names dioctyltin dilaurate and stannane, and  dioctyl-, bis(coco acyloxy) derivs.
 
With regard to the scope of the proposed entry, as explained in the SVHC report the entry proposed covers all substances that are represented by an alkyl descriptor that may also be considered for coconut fatty acids. i.e. stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety. Therefore irrespective of the name, whenever a substance has a composition that matches with the described scope, that substance is covered by the proposed entry.

In  the meantime, the registrant submitted a testing proposal to ECHA. The testing proposal examination under the REACH Regulation is a distinct and independent process from both the SVHC identification and the harmonised classification process and is aimed at fulfilling data gaps in standard information requirements of registration dossiers. This means that the SVHC entry proposal is processed irrespective of your testing proposal, as the available data is considered sufficient by the Member State submitting the SVHC proposal. (https://echa.europa.eu/regulations/reach/evaluation/examination-of-testing-proposals)
 
When a testing proposal is submitted to ECHA, as a first step the information on the identification of the substance given in the registration dossier is checked. The substance needs to be sufficiently identified in the registration dossier. If needed, ECHA contacts the registrants asking clarification on the substance identity information to be provided in the form of a registration dossier update. Until an updated dossier including this information is not submitted, the testing proposal cannot be assessed. This is to ensure that a meaningful test material is selected and that what is tested is representative of the compositions reported in the Joint Submission.
 
This happened also in the present case, the registrant was invited to provide clarification on the substance identity information included in the registration dossier. ECHA indicated that this additional information is to be submitted in the form of an updated dossier and is still awaiting for this data. 

The registrant also contacted ECHA for requesting a change of identifiers (name, EC and CAS numbers) initially used for describing the registered substance in the registration dossier. ECHA provides a service enabling companies to change the identifiers used for describing a registered substance in the case a clerical error is being made in the substance identification. Such a change may need time to be implemented because of the various actors -Joint submission members and ECHA- involved and discussions needed. One of the possible outcomes of the discussions is the splitting of the joint submission. 
 
In light of the comment provided, ECHA understands that there might have been a misunderstanding from the registrant on the next expected actions. ECHA will contact the registrant for a clarification. 

Therefore the testing proposal has not been blocked, but is in the course of being processed. To this end ECHA followed the standard procedure that is carried out for the assessment of testing proposals.
	
		Attachment: 5445_DOTL Public Consultation - Lead_OTR Response_FINAL.pdf

Confidential attachment removed
		
5450
2020/10/16	Borealis AG,
Company,
Austria		Thank you for your comment.

Please find the answer to your comment in table 3.	
		Confidential attachment removed
		
5451
2020/10/16	TIB Chemicals AG,
Company,
Germany	Authorisation under REACH is inappropriate and unnecessary under the circumstances, and Restriction based on the specific pattern of uses of the substance would be a far more appropriate approach. A targeted Restriction would maximise human health protection and prevent disproportionate regulation with significant economic and societal cost.	Thank you for your comment and for sharing your views on the most appropriate risk management option for this substance.  

Sweden has concluded that SVHC identification and authorisation for those uses covered is a relevant risk management for this substance.

Please also see the response provided for comment 5445 in Part I, table 1 above.	
		Attachment: 5451_pub annex cons dotl svhc.zip

Confidential attachment removed
		
5454
2020/10/16	Galata Chemicals GmbH,
Company,
Germany	Authorisation under REACH is inappropriate and unnecessary under the circumstances, and Restriction based on the specific pattern of uses of the substance would be a far more appropriate approach. A targeted Restriction would maximise human health protection and prevent disproportionate regulation with significant economic and societal cost.
	Thank you for your comment and for sharing your views on the most appropriate risk management option for this substance.  

Sweden has concluded that SVHC identification and authorisation for those uses covered is a relevant risk management for this substance.

Please also see the response provided for comment 5445 in Part I, table 1 above.
	
		Attachment: 5454_DOTL_SVHC_PC_2020-10-16.pdf

5455
2020/10/16	SONGWON International AG,
Company,
Switzerland	Given the significant burden (both for industry and regulators) it would be ill-advised to move on the SVHC listing of this substance until the new scientific evidence has been fully evaluated.  It is quite possible that the Reprotoxic 1B classification that served as the justification for the SVHC proposal by Sweden will in fact be unjustified (i.e. DOTL does not fulfil all the criteria required to be included in the SVHC list).  We are therefore recommending that the SVHC proposal be postponed until the new study has been reviewed and assessed by MSC and RAC.

Putting aside the pending availability of new information which could completely invalidate the basis for the SVHC proposal, we recognize that the current harmonized classification as Repr. 1B does make DOTL eligible for SVHC identification and potential Authorization under REACH.  Even so, SONGWON believes that SVHC listing is inappropriate and unnecessary under the current and reasonably foreseeable processing and use conditions of DOTL.
A more appropriate approach would be a Restriction based on DOTL's specific pattern of uses.  A targeted Restriction could be limited to those uses where there is significant exposure/release. This would maximize protection of human health and prevent disproportionate regulation with significant economic and societal cost.
	Thank you for your comment and for sharing your views on the most appropriate risk management option for this substance.  

Please also see the response provided for comment 5445 in Part I, table 1 above.

Sweden has concluded that SVHC identification and authorisation for those uses covered is a relevant risk management for this substance.	
		Attachment: 5455_Songwon ECHA public consultation on Dioctyltin dilaurate DOTL.pdf

Table 2. Specific comments on the justification
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5426
2020/09/25	ANSES,
National Authority,
France	The harmonised classification Repr 1B-H360D of these substances fulfils the criteria to identify the substances as SVHC under article 57(c) and the SVHC identification is supported.	Thank you for your support.	
5430
2020/10/02	Kaneka Belgium N.V.,
Company,
Belgium	We would like to thank ECHA for providing the opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a substance of very High Concern (SVHC) under REACH.
Kaneka Belgium N.V. uses DOTL for the following purposes : Development of sealants and adhesives based on silane terminated polyethers for the Do-It-Yourselves, consumer, industrial and construction market.  DOTL is present as catalyst to cure the sealants and adhesives after applying.
	Thank you for the information provided. 
	
5436
2020/10/13	Ramsauer GmbH & Co KG,
Company,
Austria	Ramsauer GmbH & Co KG uses DOTL as a catalyst as a cross-linking agent during the curing process of sealants or adhesives in far-below stoichiometric amounts (always below 0,5 %, typically below 0,1 %).

The catalyst is physically bound into the matrix of the adhesive/sealant, therefore the risk for human exposure can be considered as minor. The only route of possible exposure could be unintended skin contact to the sealant/adhesive prior to the curing process, which typically takes less than 30 minutes. The very low risk of unintended skin contact during the curing time can be easily prevented by protective clothing, e.g. gloves.

The expected consequences for our business due to a broad ban on DOTL in the EU will start from a complete reformulation of the receipt of our best-established products on the market, as DOTL as the catalyst is the very heart of the product. A loss of this even at low-concentrations extremely well-performing catalyst would lead to a strong loss of performance of the products, threatening the validity of cost-intensive certificates obtained for the application of the sealants/adhesives in special areas (construction industry, food sector, automotive industry, cleanroom, etc) . Currently there aren’t any alternative catalysts with the same properties available on the market to substitute DOTL in the formulations. Therefore it would not be possible to keep the high quality of our adhesives/sealants and to meet the requirements of the customers. A loss of customers would be inevitable, as the competitiveness with non-EU suppliers would not be given anymore.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
5437
2020/10/13	Health and Environment Alliance (HEAL),
International NGO,
Belgium	The Health and Environment Alliance (HEAL) thanks Sweden for its proposal to list dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs as substances of very high concern under article 57(c), which we fully support. Because dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs are classified in the hazard class toxic for reproduction category 1B under the CLP regulation, we consider the proposed SVHC identification to be unequivocal.	Thank you for your support.	
5440
2020/10/14	European Environmental Bureau (EEB),
International NGO,
Belgium	The EEB supports the proposal submitted by Sweden to identify Dioctyltin dilaurate and stannane, dioctyl-, bis(coco acyloxy) derivatives as well as any other stannane, dioctyl-, bis(fatty acyloxy) derivatives wherein C12 is the predominant carbon number of the fatty acyloxy moiety as Substance of Very High Concern due to its reproductive toxicity. The substance is classified in the hazard class toxic for reproduction 1B and may harm the unborn child. The substance should be added to the Candidate List and prioritised for further regulatory risk management measures.	Thank you for your support.	
5443
2020/10/15	FEICA,
Industry or trade association,
Belgium	See the corresponding embedded attachment in table 1 of Part I: 5443_DOTL public consultation SVHC 201016.pdf	Thank you for your comment.

Please find the answer to your comment in table 3.	
5444
2020/10/15	Padanaplast S.r.l,
Company,
Italy	
Confidential attachment removed	Thank you for your comment.

Please find the answer to your comment in table 1.	
5445
2020/10/16	ReachCentrum SA acting on behalf of the interested Members of the OrganoTin REACH Consortium,
Company,
Belgium	We would like to thank ECHA for the opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL; EC 222-883-3; CAS 3648-18-8) as a Substance of Very High Concern (SVHC) under the REACH Regulation. Please note, that we are submitting these comments on behalf of the Lead Registrant (TIB) with the support of the interested Members of the OrganoTin REACH Consortium.

I. Introduction
The harmonized classification of DOTL as Repr. 1B was based on read across from scientific data of Dioctyltin dichloride (DOTC). This harmonized classification has been included in the 15th ATP of the CLP Regulation, that shall apply from 1 March 2022. This harmonized classification was adopted by the RAC against the recommendation and advice of the industry that consider that read across from DOTC was not adequate.  Unfortunately, the scientific rationale provided by registrants of DOTL during the CLH public consultation and opposed to the Repr. 1B classification, were not accepted.
Furthermore, a testing proposal by registrants to definitively assess the reproductive hazard of DOTL has been blocked due to debate about the substance identity (SID) of the substance, however, this debate did not block the SVHC identification process of the substance.

II. History of the DOTL Case
The harmonized classification as Toxic to Reproduction, Category 1B (Repr. 1B) was assigned to DOTL based on read-across from data available for other substances. However, when establishing their opinion to recommend such classification, RAC did not take into consideration the scientific arguments provided by the companies that registered the substance under the REACH. Moreover, the registrants of DOTL feel that an unfair situation has been created in relation to the regulatory procedures imposed on DOTL, which has prevented them from generating key additional information in time which could lead to significantly different conclusions in relation to the proper classification for the substance. In the meantime, a proposal has been issued on the potential identification of DOTL as a Substance of Very High Concern (SVHC), which could lead to the inclusion of the substance in REACH Annex XIV (the Authorisation list), which would trigger significant challenges for industry and likely negative socio-economic impacts for the EU. The following aims at summarizing the history of the various actions that have been triggered for DOTL under REACH and CLP over the past 5 years.

Harmonised Classification and Labelling (CLH)
On 18 September 2015, Sweden informed of the intention to issue a CLH proposal for DOTL, including classification as Repr. 1B. The proposal was submitted on 14 August 2017. A public consultation was opened for stakeholders to deliver their comments on the proposal. DOTL registrants provided a set of scientific and technical comments, however those were not taken into consideration by RAC when establishing their final opinion on the case (on 14 September 2018), which was in agreement with the submitter of the proposal. The comments are available on the ECHA Website.
(https://echa.europa.eu/de/harmonised-classification-and-labelling-previous-consultations/-/substance-rev/17823/term?_viewsubstances_WAR_echarevsubstanceportlet_SEARCH_CRITERIA_EC_NUMBER=222-883-3&_viewsubstances_WAR_echarevsubstanceportlet_DISS=true)
The classification was established by read-across from data available on Dioctyltin dichloride (EC 222-583-2, CAS 3542-36-7) based on hydrolytic and toxicokinetic behavior, and it was delivered to the European Commission for inclusion of the harmonized classification of DOTL in the 15th ATP to the CLP Regulation.
In order to defend their position, in 2019 the Lead Registrant of DOTL delivered two letters, one to the EU Ombudsman, highlighting the inaccuracy of RAC’s position, and another one to the Directorate General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) of the European Commission, requesting a postponement of the inclusion of DOTL in the 15th ATP. Requests from the Lead Registrant were not further processed by the letter recipients.
On 19 May 2020, the 15th ATP (Regulation 2020/1182) was published, including the Repr. 1B classification for DOTL. This was later included in the Official Journal of the EU on 11 August 2020.

Testing proposal – Substance Identity (SID)
On 11 September 2018, the registration dossier of DOTL was updated by the Lead Registrant, including a testing proposal for a Prenatal Developmental Toxicity study (PNDT) in rats, under OECD TG 414.
During 2019, a number of teleconferences were held between the registrants and ECHA (March and April), in addition to significant e-mail communication throughout the whole year.
During the teleconferences the registrants expressed their intention to identify DOTL as a   “Reaction product of Dioctyltinoxide and Fatty Acids C12-18 even numbered saturated”.
ECHA confirmed in writing that an “alkyl chain-based name would be appropriate to identify the registered substance”
During the substance Identity change process, the submitted joint submission plan was rejected since in the meanwhile Sweden had started an RMOA and the substance identifier could not be changed since a regulatory process was ongoing.
In the ROI of SVHC Intentions Sweden uses surprisingly in addition to “Dioctyltin dilaurat and dioctyl-, bis(coco acyloxy) derivs.” the name “stannane, dioctyl-, bis(fatty acyloxy) derivs.” wherein C12 is the predominant carbon number of the “fatty acyloxy moiety” an identifier which in its core is identical with the one proposed by the registrants but rejected by ECHA.
The registrants felt trapped when ECHA informed that the testing proposal could not be further processed because there was a disagreement with the SID information that the registrants had provided in the registration dossier. Until SID issues are clarified, evaluation of testing proposals cannot be processed by ECHA, which means that the studies proposed need to be put on hold.

Regulatory Management Option Analysis (RMOA)
On 17 October 2019, the Lead Registrant was informed via the REACH-IT platform that the change in SID could not be processed, because another regulatory process was in place for DOTL.
Indeed, on 23 September 2019, the Swedish Chemicals Agency (KEMI) issued an intention to prepare an RMOA for DOTL. This RMOA, which was concluded on 12 February 2020, stated that the substance should be identified as an SVHC, due to its classification as Repr. 1B. The RMOA from Sweden also covered substance “stannane, dioctyl-, bis(coco acyloxy) derivs”, EC 293-901-5, CAS 91648-39-4, and included a reference to “any other stannane, dioctyl-, bis(fatty acyloxy) derivs, wherein C12 is the predominant carbon number of the fatty acyloxy moiety”.

SVHC identification
On 12 February 2020 Sweden presented an intention to the Registry of SVHC intentions (ROI) proposing DOTL as a SVHC due to its reprotoxic behavior, according to Article 57c of the REACH Regulation. The Annex XV report for the substance was submitted by Sweden on August 2020 and the Public consultation was launched on 1 September 2020. The deadline for commenting has been fixed on 16 October 2020.

Chronology
- 18 September 2015: Intention to issue a CLH proposal for DOTL.
- 14 August 2017: submission of CLH proposal.
- 11 September 2018: update of the registration dossier including a testing proposal.
- 14 September 2018: RAC decision on CLH proposal.
- 6 March 2019: Letter from Lead Registrant to Ombudsman.
- 29 March 2019: ECHA communication stating that the testing proposal could not be evaluated due to SID uncertainties.
- April - December 2019: extensive communication via e-mail and teleconference between registrants and ECHA on the SID issue.
- 7 June 2019: Letter from Lead Registrant to DG Grow.
- 23 September 2019: intention from Sweden to prepare an RMOA on DOTL
- 17 October 2019: communication via REACH-IT to Lead Registrant that the SID update could not be processed due to another regulatory process on-going.
- 12 February 2020: conclusion of the RMOA by Sweden, with a recommendation to identify DOTL as SVHC. Presentation of the SVHC intention to the ROI.
- 19 May 2020: publication of 15th ATP including the harmonized classification of DOTL.
- 11 August 2020: inclusion of the 15th ATP in the Official Journal of the EU.
- 1 September 2020: launch of the public consultation to identify DOTL as SVHC.

III. New OECD 414 Study
A new GLP PNDT study (OECD 414), conducted by the preclinical pharmaceutical development division of Covance (for regulatory purposes in South Korea/Korea REACH and USA), is available in draft status. A summary of the study and an initial evaluation by a scientific expert is attached as separate document and has been uploaded in the confidential section. The objective of the study was to determine the effects of the test article Dioctyltin dilaurate (DOTL) on the prenatal development of the rat. The toxicokinetic profile of the test article was also assessed. This study results would demonstrate that DOTL is not Toxic to Reproduction, Category 1B (Repr. 1B), so the SVHC qualification is void and Article 57c of the REACH Regulation is not fulfilled.
Furthermore, the data in the relevant endpoints in the registration dossier demonstrates, that a classification of DOTL as STOT SE is appropriate and not a classification as STOT RE1.

VI. Conclusion
While in principle the harmonized classification as Repr. 1B would make DOTL eligible for SVHC identification and potential Authorisation under REACH, the Consortium believes that this is inappropriate and unnecessary under the described circumstances.
Moreover, new scientific evidence is becoming available suggesting that DOTL is actually not Repr. 1B. Therefore, it does not appear to be efficient to move forward the SVHC listing of this substance until the above mentioned new scientific evidence has been fully evaluated, given the significant burden (both for industry and regulators) that could be derived from including a substance in the SVHC list that may not fulfil all the criteria required to be included in the list.
We are therefore asking that the SVHC listing be postponed, until the study has been scrutinized by MSC and RAC. Removing a SVHC substance from the candidate list due to unjustified science will be an inefficient and burdensome procedure for ECHA, Member States and Industry.
For any questions or clarification, please do not hesitate to contact us.

Sincerely
On behalf of the interested Members of the OrganoTin Consortium
	Thank you for your comments and the information provided. 

Please see the response provided to your comment in Part I, table 1 above.	
		See the corresponding embedded attachment in table 1 of Part I: 5445_DOTL Public Consultation - Lead_OTR Response_FINAL.pdf
		
5446
2020/10/16	CHEM Trust Europe,
National NGO,
Germany	CHEM Trust supports the inclusion of dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs.; as well as any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety in the REACH candidate list based on their classification in the hazard class toxic for reproduction category 1B. These substances meet the criteria of REACH article 57c). In addition, we propose the inclusion should also be based on article 57f given the well known endocrine disrupting properties of organotin compounds.	Thank you for your support.	
5447
2020/10/16	Austria,
Member State	The Austrian CA agrees with the identification of "Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety" as substances of very high concern as the requirements of Article 57(c) are fulfilled. Furthermore, this is in line with risk reduction measures already initiated for other similar organotin compounds in order to avoid regrettable substitution.	Thank you for your support.	
5450
2020/10/16	Borealis AG,
Company,
Austria	
Confidential attachment removed	Thank you for your comment.

Please find the answer to your comment in table 3.	
5451
2020/10/16	TIB Chemicals AG,
Company,
Germany	The RAC decision and the subsequent 15th ATP affected the substances Diocyltin dilaurate (EC# 222-883-3) and Stannane, dioctyl-, bis(cocoacyloxy) derivs. (EC# 293-901-5). The substance any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety (EC# 951-681-4) is not affected.
Therefore, the naming of EC# 951-681-4 as svhc substance is not covered by Regulation (EC) No. 1907/2006 Article 57 c and / or f.
The harmonized classification of DOTL as Repr. 1B, based on read across from Dioctyltin dichloride (DOTC), was adopted by the RAC against the recommendation and advice of the industry, that consider that read across from DOTC was not adequate. Nor KEMI neither RAC considered the information (e.g. DOTL: toxicity for reproduction, immunotoxicity; DOTC immunotoxicity) in both registration dossiers. The read across in the registration dossier based on an in-vivo study not on hypothesises (see public Annex I).
So, there may be an objection to Regulation (EC) No.  1272/2008 Article 37 para 1 subpara 2 and Annex VI Part 2 para 3 sentence 1:"For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used."

A testing proposal by registrants to assess the reproductive hazard of DOTL has been delayed (history see public Annex II). However, new scientific evidence is becoming available that suggest that DOTL is not Repr. 1B (see confidential Annex I, II, III). Therefore, it does not appear to be efficient to move forward the SVHC listing of this substance until the above mentioned new scientific evidence has been fully evaluated.
	Thank you for your comment.

Please see the response provided for comment 5445 in Part I, table 1 above.
	
		See the corresponding embedded attachment in table 1 of Part I: 5451_pub annex cons dotl svhc.zip

Confidential attachment removed		
5453
2020/10/16	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of dioctyltin dilaurate and related compunds as SVHCs, based on the earlier identification as toxic for reproduction 1b. However, as organotins are well-known endocrine disruptors in the environment, the most studied effects being so called imposex in gastropods, we ask for additional identification of the substance as endocrine disruptor for the environment.
The identification of the substance as SVHC is especially important since, as presented in the dossier, the use of these compounds has increased as more and more other organotins have been targeted by regulation.	Thank you for your support.	
5454
2020/10/16	Galata Chemicals GmbH,
Company,
Germany	The harmonized classification of DOTL as Repr. 1B, based on read across from Dioctyltin dichloride (DOTC), was adopted by the RAC against the recommendation and advice of the industry, that consider that read across from DOTC was not adequate.
A testing proposal by registrants to assess the reproductive hazard of DOTL has been blocked. However, new scientific evidence is becoming available that suggest that DOTL is actually not Repr. 1B. Therefore, it does not appear to be efficient to move forward the SVHC listing of this substance until the above mentioned new scientific evidence has been fully evaluated.	Thank you for your comment.

Please see the response provided for comment 5445 in Part I, table 1 above.
	
		See the corresponding embedded attachment in table 1 of Part I: 5454_DOTL_SVHC_PC_2020-10-16.pdf		
5455
2020/10/16	SONGWON International AG,
Company,
Switzerland	The harmonized classification of DOTL as Repr. 1B (used to justify the SVHC proposal) was based on read across from Dioctyltin dichloride (DOTC).  This classification was adopted by the RAC against the recommendation and advice of the industry who maintained that the use of read across from DOTC in this case was not appropriate.   A testing proposal by registrants to assess the reproductive hazard of DOTL has been blocked by ECHA.  However, new scientific evidence is becoming available that suggest that DOTL is actually not Repr. 1B. Therefore, it does not appear to be efficient to move forward the SVHC listing of this substance until the above mentioned new scientific evidence has been fully evaluated.	Thank you for your comment.

Please see the response provided for comment 5445 in Part I, table 1 above.
	
		See the corresponding embedded attachment in table 1 of Part I: 5455_Songwon ECHA public consultation on Dioctyltin dilaurate DOTL.pdf		

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Table 3. Specific comments on use, exposure, alternatives and risks
Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
5424
2020/09/24	NITTO KASEI CO., LTD.,
Company,
Japan	DOTL is an important key material for various applications and there is no replacement which covers all of them at this time. We Nitto Kasei have been developing alternatives to those applications for a long time, but there are no alternatives due to the versatility inherent in DOTL. Since we still need time to prepare alternatives for each application, we would like to request reconsideration of the introduction of regulations at this time.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
5427
2020/09/28	EPUTAN Kunststoftechniek B.V.,
Company,
Netherlands	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a Substance of Very High Concern (SVHC) under REACH.
Eputan B.V. is using DOTL as accelerator in Polyurthane poured coatings and coatings to ensure potlife and curing time regarding applications for the coustomer. The amount of DOTL regarding the hole formulation is about 0.1 % - Regarding Emission testing Tin accelarators cant be found in the analysis '.	Thank you for the information provided. 
	
5428
2020/09/29	Geholit+Wiemer GmbH,
Company,
Germany	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a Substance of Very High Concern (SVHC) under REACH. Geholit+Wiemer GmbH produces protective coatings for industrial and professsional users. DOTL serves as curing accelerator for polyurethane protective coatings.

Potential for human health exposure:
Exposure could occur in formulation processes only if standard hygiene procedures are not applied. In standard industrial formulation processes, no oral exposure is to be ex-pected. Inhalation is not probable due to very low vapor pressure of DOTL, dermal exposure is not relevant (no skin or eye irritation).
Only very small amounts (less than 0.1 %w/w) are used in polyurethane coatings. Expo-sure for customers is reduced additionally through exposure controls due to isocyanate restrictions.
Should authorization be applied to DOTL, we would estimate socioeconomic consequences for our business: DOTL is unique in his accelerating properties to polyurethane polymerization. No substitute is known so far with only similar properties. If there where suitable alternatives to DOTL, the German hazardous materials regulations would enforce the substitution anyway.
As DOTL is used in very small amounts, non-EU manufacturers would benefit from unhindered import since authorization would not apply. This would lead to a gross distortion of competition. Loss of customers would be the consequence, as curing velocity is a key argument in industrial processes.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5429
2020/09/30	Karl Wolpers KG,
Company,
Germany	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a Substance of Very High Concern (SVHC) under REACH. Karl Wolpers KG uses DOTL for the following purposes: Catalyst in at least five sealing products.
Potential for human health exposure from our uses is as follows: We use it about one to two times per week, for about some two or three minutes during one mixing process. The potential magnitude of exposure is relativley low during a week. There is only the exposure during the pouring and at the end of the mixing process, which both can be summarized in about 5 minutes of exposure.
Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business: At least five of our main products could not be produced anymore, or at least have to be changed, unknown if it is possible to create a similar product with other materials.
The changing of recipees (if even possible) rise the risk of many financial losses, due to more controls and settings for the products as well as the disadvantage in the market in comparison to unchanged sealants from other contestants.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
5430
2020/10/02	Kaneka Belgium N.V.,
Company,
Belgium	Potential for human health exposure from our uses is as follows : Exposure to DOTL can occur during the manufacturing of the sealants and adhesives but will be minimized by wearing personal protection material.  During applying the sealant and adhesive the exposure will be minimal as the DOTL is inbedded in the paste and is not migrating.  After application the adhesive or sealant cures to a solid material and DOTL will not be released.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5431
2020/10/07	Torggler S.r.l.,
Company,
Italy	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a Substance of Very High Concern (SVHC) under REACH.

Torggler S.r.l. uses DOTL for the following purposes: Crosslinking catalysts for moisture cured one component sealants.

Potential for human health exposure from our uses is as follows:
DOTL is used in a closed process where it is automatically added to the mixture from an intermediate storage tank. DOTL is supplied in IBC and the filling of the intermediate storage tank by a manually inserted pump. The operator wears individual protective devices (goggles, gloves, coat) and therefore contact can happen only accidentally. The finished product, which contains DOTL in catalytic quantities is in paste form and filled in cartridges. The application is mainly on construction sites by professional users for sealing and glueing purposes. Exposure could occur by manually finishing the applied fresh sealant without wearing protective gloves.

Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business:
DOTL is the catalyst in our most important product group which accounts for roughly 15% of our yearly turnaround. A ban of DOTL in the EU would force us to search for alternatives. Given the importance of this product for our company, this research activities would bind a significant part of our laboratory capacities. Since one of the specificities of our product is the long open time (or tooling time) which is strictly correlated to the crosslinking velocity given by DOTL.

The DOTL containing formulations are CE marked (system 3 accordin to CPR 305/2011) and therefore a reformulation due to a ban of DOTL would also imply certification costs.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5432
2020/10/12	Reaxis B.V.,
Company,
Netherlands	Reaxis B.V. imports DOTL produced by its sister (production) company Reaxis INC. Our use of DOTL is for the following purposes: Marketing and selling DOTL to poly urethane manufacturing companies in Europe, for use in Poly urethane based formulations.
Potential for human health exposure from our uses is as follows: Logistical handling and repacking of DOTL.
Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business: Reaxis B.V.; together with its sister company Reaxis Inc (USA) will have to develop, and adjust its catalysts based on DOTL into other suitable  chemistry with similar or improved performance. This will involve an extensive amount of (R&D) labour and investments, as technical viable direct replacement alternatives are not readily available at this moment. The above will a large effect on our financial performance. During this time, a significant amount of revenue is expected to be lost as we would not be able to serve our customers in the meantime; For our downstream users the same/similar is valid. The entire cost of change (developing new catalysts/reformulating products, obtaining technical approvals, possible REACH registrations) is expected for Reaxis to be several million Euro’s. If a broad ban were to be applied, it is expected that it will lead to loss of business and related jobs; both for Reaxis and its customers. Moreover, it would weaken the competitive environment as it is expected that only the larger chemical producers will have the financial depth to develop alternatives, where SME’s would have to cease business.

DOTL is typically used as catalyst at very low dosage levels between 0.05-0.1% weight% of the total formulation. These catalysts are typically used in the catalysis of various thermoset polymers (e.g, cannot be reused/re-processed as is) whereby the DOTL is chemically bound up into the polymer network making up the final product. The main end use applications (coatings, adhesives/sealants, elastomer, and foams) typically have long usage lives (typically over 10 years). This combination of low dosage levels, the chemical binding up in a polymer network of the final products and long-term use of these final products would minimize the contact with the environment and impacts on human health.
Moreover, as a co-registrant under REACH of this substance we understand that a new study is available demonstrating that the substance is not a Repro 1b substance and that the lead registrant will submit further details.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5433
2020/10/12	Gross & Perthun GmbH & Co. KG,
Company,
Germany	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a Substance of Very High Concern (SVHC) under REACH.

Gross & Perthun GmbH & Co. KG uses DOTL for the following purposes:
- Catalyst for polyurethane based paints and coatings

Potential for human health exposure from our uses is as follows:
There is no intended exposition of DOTL for the employees. Suitable personel protective equipment (e.g. gloves and breathing protection) is used by our employees. Additionaly Exhaust devices reduce the risk of exposition towards DOTL.

The control of emissions values have shown no exeeding of threshold values concerning DOTL.

Our customers receive paints and coatings with a maximum content of 0,5 % by wght. DOTL. The paints and coatings are processed under industrial conditions.

Gross & Perthun processes DOTL sind 2009 at an anual rate of approx. 500 kg. We have currently no information about DOTL-based health issues of our employees or customers who process our products.

Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business:
- Despite intensive efforts of the research and development no comparable alternative to DOTL for the use in paints and coatings is available. Potential alternatives (e.g. bismuth-based organic compounds) have a significant worse property performance which requires the use of higher concentrations of catalyst in the paints and coatings or downgrade the properties and processing performance of the paints and coatings.
- A high development effort is required for the testing of alternative catalysts and redraft of the formulations of our current range of products (over 500 formulations).
- The ban of DOTL would be a significant disadvantage for Gross & Perthun against global competitors inside the EU, because DOTL must be declared only if the content exeeds 0,1 % by wght. Gross & Perthun would also be put in a considereably position of disadvantage when the paints and coatings are processed outside of the EU.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5434
2020/10/12	Nordmann, Rassmann GmbH ,
Company,
Germany	Nordmann, Rassmann GmbH (Hamburg, Germany, "Nordmann") distributes DOTL from our supplier REAXIS B.V. (Netherlands), produced by their sister (production) company Reaxis INC. Our use of DOTL is for the following purposes: Marketing and selling DOTL to poly urethane manufacturing companies in Europe, for use in Poly urethane based formulations.
Potential for human health exposure from our uses is as follows: Logistical handling and delivery of DOTL to our customer, e.g. manufacturers of polyurethane based adhesives, sealants, elastomers, foams and coatings.
Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business: Nordmann’s supplier Reaxis B.V.; together with their sister company Reaxis Inc (USA) will have to develop, and adjust its catalysts based on DOTL into other suitable chemistry with similar or improved performance. This will involve an extensive amount of (R&D) labour and investments at REAXIS, as technical viable direct replacement alternatives are not readily available at this moment. Nordmann will have to promote, offer, sample and implement the relevant alternatives, driving approvals at our customers. During this time, a significant amount of revenue is expected to be lost as we would not be able to serve our customers in the meantime; For our downstream users the same/similar is valid. If a broad ban were to be applied, it may be expected that it will lead to loss of business and related jobs; both for Reaxis and our related distribution customers. Moreover, it would weaken the competitive environment as it is expected that only the larger chemical producers will have the financial depth to develop alternatives, where SME’s would have to cease business.
DOTL is typically used as catalyst at very low dosage levels between 0.05-0.1% wt% of the total formulation. These catalysts are typically used in the catalysis of various thermoset polymers (e.g, cannot be reused/re-processed as is) whereby the DOTL is chemically bound up into the polymer network making up the final product. The main end use applications (coatings, adhesives/sealants, elastomer, and foams) typically have long usage lives (10 years+). This combination of low dosage levels, the chemical binding up in a polymer network of the final products and long-term use of these final products would minimize the contact with the environment and impacts on human health. The main risk for human/environmental contact comes during the formulation and production of the DOTL and the related end-use products and thus more stringent handling precautions could be taken based on the acute toxicity characteristics.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5435
2020/10/13	Nordmann, Rassmann Handels-GmbH,
Company,
Austria	Nordmann, Rassmann Handels-GmbH (Vösendorf, Austria, “Nordmann”) distributes DOTL from our supplier REAXIS B.V. (Netherlands), produced by their sister (production) company Reaxis INC. Our use of DOTL is for the following purposes: marketing and selling DOTL to Polyurethane manufacturing companies in Europe, for use in Polyurethane based formulations.
Potential for human health exposure from our uses is as follows: logistic handling and delivery of DOTL to our customers, e.g. manufacturers of Polyurethane based adhesives, sealants, elastomers, foams and coatings.
Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business: Nordmann’s supplier Reaxis B.V.; together with their sister company Reaxis Inc (USA) will have to develop and adjust its catalysts based on DOTL into other suitable chemistry with similar or improved performance. This will involve an extensive amount of (R&D) labour and investments at REAXIS, as technical viable direct replacement alternatives are not readily available at this moment. Nordmann will have to promote, offer, sample and implement the relevant alternatives, driving approvals at our customers. During this time, a significant amount of revenue is expected to be lost as we would not be able to serve our customers in the meantime; for our downstream users the same/similar is valid. If a broad ban were to be applied, it may be expected that it will lead to loss of business and related jobs; both for Reaxis and our related distribution customers. Moreover, it would weaken the competitive environment as it is expected that only the larger chemical producers will have the financial depth to develop alternatives, where SME’s would have to cease business.
DOTL is typically used as catalyst at very low dosage levels between 0.05-0.1% wt% of the total formulation. These catalysts are typically used in the catalysis of various thermoset polymers (e.g, cannot be reused/re-processed as is) whereby the DOTL is chemically bound up into the polymer network making up the final product. The main end use applications (coatings, adhesives/sealants, elastomer, and foams) typically have long usage lives (longer than 10 years). This combination of low dosage levels, the chemical binding up in a polymer network of the final products and long-term use of these final products would minimize the contact with the environment and impacts on human health. The main risk for human/environmental contact comes during the formulation and production of the DOTL and the related end-use products and thus more stringent handling precautions could be taken based on the acute toxicity characteristics.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5439
2020/10/14	Nordmann, Rassmann Polska sp. z o.o.,
Company,
Poland	Nordmann, Rassmann Polska sp. z o.o. distributes DOTL from our supplier REAXIS B.V. (Netherlands), produced by their sister (production) company Reaxis INC. Our use of DOTL is for the following purposes: marketing and selling DOTL to polyurethane manufacturing companies in Europe, for use in polyurethane based formulations.
Potential for human health exposure from our uses is as follows: logistical handling and delivery of DOTL to our customer, e.g. manufacturers of polyurethane based adhesives, sealants, elastomers, foams and coatings.
Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business: Nordmann’s supplier Reaxis B.V.; together with their sister company Reaxis Inc (USA) will have to develop, and adjust its catalysts based on DOTL into other suitable chemistry with similar or improved performance. This will involve an extensive amount of R&D labour and investments at REAXIS, as technical viable direct replacement alternatives are not readily available at this moment. Nordmann will have to promote, offer, sample and implement the relevant alternatives, driving approvals at our customers. During this time, a significant amount of revenue is expected to be lost as we would not be able to serve our customers in the meantime. For our downstream users the same/similar is valid. If a broad ban were to be applied, it may be expected that it will lead to loss of business and related jobs; both for Reaxis and our related distribution customers. Moreover, it would weaken the competitive environment as it is expected that only the larger chemical producers will have the financial depth to develop alternatives, where SME’s would have to cease business.
DOTL is typically used as catalyst at very low dosage levels between 0.05-0.1% wt% of the total formulation. These catalysts are typically used in the catalysis of various thermoset polymers (e.g, cannot be reused/re-processed as is) whereby the DOTL is chemically bound up into the polymer network making up the final product. The main end use applications (coatings, adhesives/sealants, elastomer, and foams) typically have long usage lives (more than 10 years). This combination of low dosage levels, the chemical binding up in a polymer network of the final products and long-term use of these final products would minimize the contact with the environment and impacts on human health. The main risk for human/environmental contact comes during the formulation and production of the DOTL and the related end-use products and thus more stringent handling precautions could be taken based on the acute toxicity characteristics.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5440
2020/10/14	European Environmental Bureau (EEB),
International NGO,
Belgium	The substance has a wide dispersive use in the EU, including widespread use by professional workers and consumers. The substance may be used increasingly as a replacement for dibutyltin compounds as well as other dioctyltin compounds that are currently recommended for inclusion in Annex XIV (DOTE and reaction mass of DOTE:MOTE). Therefore the substance should be considered for inclusion in Annex XIV taking into account grouping considerations regarding other organotin compounds to prevent regrettable substitution.
	Thank you for your support.	
				
5442
2020/10/15	Individual,
Switzerland	prochem AG distributes DOTL from our supplier REAXIS B.V. (Netherlands), produced by their sister (production) company Reaxis INC. Our use of DOTL is for the following purposes: Marketing and selling DOTL to poly urethane manufacturing companies in Europe, for use in Polyurethane based formulations.
Potential for human health exposure from our uses is as follows: Logistical handling and delivery of DOTL to our customer, e.g. manufacturers of polyurethane based adhesives, sealants, elastomers, foams and coatings.
Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business: prochem’s supplier Reaxis B.V.; together with their sister company Reaxis Inc (USA) will have to develop, and adjust its catalysts based on DOTL into other suitable chemistry with similar or improved performance. This will involve an extensive amount of (R&D) labour and investments at REAXIS, as technical viable direct replacement alternatives are not readily available at this moment. prochem will have to promote, offer, sample and implement the relevant alternatives, driving approvals at our customers. During this time, a significant amount of revenue is expected to be lost as we would not be able to serve our customers in the meantime; For our downstream users the same/similar is valid. If a broad ban were to be applied, it may be expected that it will lead to loss of business and related jobs; both for Reaxis and our related distribution customers. Moreover, it would weaken the competitive environment as it is expected that only the larger chemical producers will have the financial depth to develop alternatives, where SME’s would have to cease business.
DOTL is typically used as catalyst at very low dosage levels between 0.05-0.1% wt% of the total formulation. These catalysts are typically used in the catalysis of various thermoset polymers (e.g, cannot be reused/re-processed as is) whereby the DOTL is chemically bound up into the polymer network making up the final product. The main end use applications (coatings, adhesives/sealants, elastomer, and foams) typically have long usage lives (more then 10 years). This combination of low dosage levels, the chemical binding up in a polymer network of the final products and long-term use of these final products would minimize the contact with the environment and impacts on human health. The main risk for human/environmental contact comes during the formulation and production of the DOTL and the related end-use products and thus more stringent handling precautions could be taken based on the acute toxicity characteristics.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
				
5443
2020/10/15	FEICA,
Industry or trade association,
Belgium	FEICA, the Association of the European Adhesive & Sealant Industry, is a multinational association representing the European adhesive and sealant industry. Today's membership stands at 15 National Association Members, 25 Direct Company Members and 19 Affiliate Company Members. The European market for adhesives and sealants is currently worth more than 17 billion euros. With the support of its national associations and several direct and affiliated members, FEICA coordinates, represents and advocates the common interests of our industry throughout Europe. In this regard, FEICA works with all relevant stakeholders to create a mutually beneficial economic and legislative environment.
We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL; EC 222-883-3; CAS 3648-18-8) as a Substance of Very High Concern (SVHC) under the REACH Regulation.
DOTL is a significant commercial product in Europe. It is used predominantly as catalyst, including in the manufacture of adhesives and sealants.
The main function of DOTL is its catalytic activity. In this application the substance is the most efficient catalyst, and it brings unique properties to the products. Also, it is essential to accelerate the polyurethane, silicone and silane modified polymer cure reaction and shorten the reaction time, and this impacts on energy saving. Moreover, the use of DOTL for catalyst applications is considered to be safe.
Due to the wide use of this substance, any regulatory action or ban on the substance could have significant socio-economic impacts in the EU. SMEs account for 20% of the use of organotin catalyst. A significant amount of organotin catalyst is sold in the adhesive market. Moreover, adverse impacts through increased costs of alternatives would occur, even if those alternatives existed. Also, the adhesive market could be impacted by cheaper products coming outside the EU still using organotin catalyst.
Formulators of adhesives and sealants often customise polymers, which results in new polymer species. Such customisation is required in order to fulfil technical feasibility and customer requirements as well as regulatory needs. Without such customised polymers, end users would be left with products of higher hazard profile or insufficient performance. To allow for customization, the variety of catalysts at the disposal of the adhesives and sealants industry should be ensured.
The on-going discussion about DOTL and other organotin substances has led to intensive attempts to find alternatives, but there are currently no suitable alternatives for all applications.
Alternative formulations that do not contain organotin exhibit increased curing times and require higher amounts of alternative catalysts to be added, which in most cases results in a cost increase.  Some alternative catalysts become less active during storage of the adhesive, which results in reduced and unreliable curing speed of the product. In addition, most catalysts have lower reactivity than tin catalysts which makes it very difficult to achieve the right curing speeds.
The alternative catalysts will also affect the mechanical and adhesion properties of the final products, meaning a lot of research and development time needs to be spend to reformulation of sealants and adhesives and changing other raw materials. The reformulation rarely results in a product with exactly the same properties and often leads to an inferior product, since other catalysts are not as selective and also may even catalyse other undesired reactions.
For certain ecolabels, as for instance the German Blue Angel, positive lists of raw materials allowed to use to get the certification exist.  One of the approved catalysts is DOTL and is the only approved catalyst which has a high enough efficiency to cure reactive silane-based adhesives and sealants.
This means that listing DOTL in the SVHC list will result in difficult substitution and re-formulation, leading to unnecessary changes in technology, and will turn against the EU approach to sustainable development (increase in energy consumption).
Under these circumstances a far more appropriate approach would be a Restriction based on its specific pattern of uses.  A targeted Restriction could be limited to those uses where there is actual potential for exposure. This would maximise human health protection and prevent disproportionate regulation with significant economic and societal cost.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.

Thank you for sharing your views on the most appropriate risk management option for this substance.  

Sweden has concluded that SVHC identification and authorisation for those uses covered is a relevant risk management for this substance.	
		See the corresponding embedded attachment in table 1 of Part I: 5443_DOTL public consultation SVHC 201016.pdf		
5444
2020/10/15	Padanaplast S.r.l,
Company,
Italy	
Confidential attachment removed	Thank you for your comment.

Please find answers to your comment in table 1.	
5445
2020/10/16	ReachCentrum SA acting on behalf of the interested Members of the OrganoTin REACH Consortium,
Company,
Belgium	See the corresponding embedded attachment in table 1 of Part I: 5445_DOTL Public Consultation - Lead_OTR Response_FINAL.pdf

Confidential attachment removed	Thank you for your comment.

Please find the answer to your comment in Part I, table 1.	
5449
2020/10/16	Spekem S.r.l.,
Company,
Italy	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a Substance of Very High Concern (SVHC) under REACH.
Spekem S.r.l. located in Casalpusterlengo (LO) - Italy uses DOTL for the following purposes: to formulate, to produce and to sell a special catalyst for the coating industry.
Potential for human health exposure from our uses is as follows:
- during the formulation, the inhalation is possible but a self-supporting suction arm is a technical solution for the suction of gas, vapours, aerosol, etc. in compliance with the law, removing hazardous fumes and polluting substances from the working place. The work in the lab with DOTL is limited to less than 10 days/year.
- during the production the inhalation is possible but the self-supporting suction arm remove hazardous fumes and polluting substances from the working place. Further, the operators wearing an appropriate personal protective equipment to perform the task.  The production lots where DOTL is used as a raw material are up to 10/year.
- during the storage an exposure is not possible. If a spillage occur, the formulated catalyst is collected in a suitable tank under the racks. Additionally, the DOTL has an high boiling point and a low vapor pressure, so the evaporation rate is very low.
The varnishes and enamels of our customers containing our special catalyst DOTL based, are tipically sold to professional users, so a human exposure is not expected or absolutely limited.
Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business:
as we believe the DOTL is not replaceable, we expect to lose all our customers and considering that our product is used by our customers in a range of 0,1-1%, every kg we didn’t sell means at least 100kg up to 1 ton of varnish or enamel not produced. Our formulated catalyst based on DOTL is just at the early stage with good potential of sales and we have produced 1 ton during 2019.
From the technical point of view, if the catalyst is not used in the varnish, it lead to a delayed drying and curing time with the necessity to cure the applied varnish in the oven at high temperature with the related costs (and pollution), definitely higher if compared to a very small percentage of catalyst.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.

5450
2020/10/16	Borealis AG,
Company,
Austria	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a Substance of Very High Concern (SVHC) under REACH.

Borealis AG uses DOTL for the following purposes: cross-linking catalyst for cable products.

Due to the excellent electrical properties of low density polyethylene (LDPE), the cable business has been the driving force to further develop the high-pressure polymerisation process of polyethylene (PE). Today, Borealis is the world-leading supplier of these materials for cables ranging from communication cables to high voltage power cables. These cables are used underground, overhead, across the oceans, in buildings, tunnels, vehicles, ships, trains etc..
For power cables, most commonly the polyethylene needs to be crosslinked (XLPE), as in a power cable network the temperature can under certain circumstances rise above the melt temperature of ordinary LDPE. To avoid that the insulation will melt away from the conductor during such circumstances the PE is crosslinked at the cable makers.
The original processes for crosslinking of PE were using peroxides or irradiation, both invented in the end of the nineteen fifties. Irradiation curing is expensive and only working well for thin objects. For thicker power cables used for voltages above 6000 V, peroxide crosslinking is the main technology used today. However, for voltages below 6000 V the more cost efficient PVC has been the dominating material for a long time. However, in 1968 one further process for crosslinking PE was developed. In this process a silane group (about 1w-%) is connected to the PE molecule either by grafting, by the so-called Sioplas or Monosil process, or by copolymerisation. The original crosslinking catalyst for silane crosslinking was dibutyltin dilaurate (DBTL), used in concentrations of less than 0.2%. When the crosslinking catalyst is introduced into the insulation, it starts to crosslink by taking up water from the surroundings. To speed up this process the cables are often put in a sauna or water bath. In this, so-called silane or moisture curing process of PE, the crosslinking catalyst is commonly added via a catalyst master batch consisting of catalyst and standard PE. Typically, 5 w-% of such master batch is added to the silane containing PE in the extruder making the cable.
This moisture curing processes made XLPE the material of choice also for cables operating below 6000V. It allows higher operating temperatures as well as a thinner insulation thickness than PVC alternatives. Furthermore, it is free of halogens which is essential for fire safety reasons.
Borealis has further developed the moisture curing process by introducing an ambient curing catalyst, which is free of tin and instead based on a Bronsted acid. This technology was introduced in the end of the nineties (Ambicat) and we have been able to replace most of our tin-catalysts by this technology. However, it is not working for all cables and especially not for cables requiring high level of flame retardancy and low level of smoke generation. As the halogen free flame-retardants commonly used in cables, i.e. aluminium hydroxide, magnesium hydroxide and calcium carbonate are all basic, they are killing the crosslinking activity of Ambicat. So for this segment an organotin-catalyst like DBTL or DOTL is still needed. Borealis has performed extensive research in this field since 1984 to find better alternatives. In 2008 we substituted DBTL by DOTL as this has been recognised to be a safer alternative. However, until today no tin-free alternative has been found for the cables containing basic additives such as the above mentioned non-halogenated flame retardants.
The alternative processes to Borealis Visico (ethylene silane copolymer)/Ambicat technology, i.e. Monosil and Sioplas are still using DBTL even for standard cables.

Potential for human health exposure from our uses is as follows:
We consider the human exposure from our use of DOTL very low. We receive the substance in the form of a liquid in drums at our plants. Workers handling the liquid are protected using respiratory and splash protection. The catalyst masterbatches are compounded and contain less than 4% of DOTL which is encapsulated in the polymer matrix. The compounding step is done under local exhaust ventilation. At the cable manufacturer’s site usually 5%(wt) of the masterbatch are compounded with 95% of silane containing PE, which results in levels of the tin catalyst below 0.2%(wt) in the final cable which is below the applicable classification threshold. During the crosslinking process the DOTL is neither consumed nor converted but stays embedded in the polymer matrix. The cables are only handled by professional workers and usually do not get into contact with consumers under normal foreseeable conditions of use.

Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business:
Borealis has been looking for appropriate replacements for DOTL for over a decade without finding a similar product that would match its performance with an industry scale availability. Based on these learnings we have to conclude that if Borealis had to stop using DOTL the business linked to DOTL would also cease to exist without replacement. This means a significant loss of profitable sales. In the worst case, this implies that existing investments are stopped or not started and production lines are underutilized with the consequence being a reduction in workforce. More details on actual impact on sales figures are submitted in the confidential section.

In Borealis we have been looking into alternatives for organotin catalyst for many years. Back in 2008 we switched from the use of DBTL to the at least at the time considered less hazardous alternative DOTL. DBTL is also currently more severely restricted than DOTL and has been re-classified to Repr. 1B four years earlier than DOTL. We have difficulties to understand why DBTL has not been proposed to be identified as SVHC whereas DOTL currently is. Following the proposed route for DOTL alone would give an incentive to companies that are still using DBTL on the one hand and promote switching back to DBTL for other companies, leading to regrettable substitution on the other hand. We therefore ask for a timely and consistent regulatory approach for the whole functional group of organotin catalysts.
Besides the socio-economic impact to Borealis, there would also be a decrease in societal benefits if a broad ban were applied to DOTL in the EU. The reason for this is that nearly half of DOTL at Borealis is used for flame retardant photovoltaic cables. Our solution is promoting the growth of renewable energy use thereby enabling a faster move away from fossil fuels. There are no known better alternatives for our material in this segment today and the existing alternatives are potentially more harmful by containing, among others, halogens to minimize the spread of flames.
In addition, if authorisation were applied to organotin catalysts it would mean a competitive disadvantage for the European chemical and cable industries. While the use of the catalyst and the masterbatch would fall under authorisation, the final cables could be freely imported from outside EU.

Considering all of the above, the negligible exposure for industrial and professional workers as well as for consumers resulting from the catalyst use and the final cable use and handling, the lack of more sustainable alternatives, the big socio-economic impact, we believe that authorisation is not a proportionate measure for DOTL specifically, and organotin catalysts as a functional group in general.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.

		Confidential attachment removed		
5451
2020/10/16	TIB Chemicals AG,
Company,
Germany	DOTL is used predominantly as catalyst in the manufacture of silicones, coatings, adhesives, sealants, rigid and flexible foams, etc. The substance exhibits a good balance between processability and curing speed, high stability, and low migration rates. Moreover, the use of DOTL for catalyst applications is considered to be safe.
Due to the wide use of this substance, any regulatory action or ban on the substance could have significant socio-economic impacts in the EU: most of the users are SMEs, substitution (if possible) will take long time, and it will affect millions of recipes. So, the conversion costs can reach several billion of euros.
For most applications (coatings, adhesives, sealants, silicones, and others) no suitable alternatives were found during this time: metal carboxylates reduce the stability and Amines show significantly higher migration rates than DOTL. In general, these alternatives show technical disadvantages. This means that listing DOTL in the SVHC list will result in impracticable substitution and re-formulation, leading to unnecessary changes in technology, and will turn against the EU approach to sustainable development.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.
	
		See the corresponding embedded attachment in table 1 of Part I: 5451_pub annex cons dotl svhc.zip

Confidential attachment removed		
5454
2020/10/16	Galata Chemicals GmbH,
Company,
Germany	DOTL is used effectively and predominantly as catalyst in the manufacture of a variety of polyurethane applications, including rigid foams, varnish and powder coatings. These products also catalyze processes for manufacturing polyester polyols and other polyester products.
Moreover, the use of DOTL for catalyst applications is considered to be safe.
Due to the wide use of this substance, any regulatory action or ban on the substance could have significant socio-economic impacts in the EU, the conversion costs can reach several billion of euros.
For most applications no suitable alternatives were found during this time. In general, potential alternatives show technical disadvantages. This means that listing DOTL in the SVHC list will result in impracticable substitution and re-formulation, leading to unnecessary changes in technology, and will turn against the EU approach to sustainable development.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.	
		See the corresponding embedded attachment in table 1 of Part I: 5454_DOTL_SVHC_PC_2020-10-16.pdf		
5455
2020/10/16	SONGWON International AG,
Company,
Switzerland	DOTL is used mainly a catalyst used in the manufacture of crosslinked polymer systems including silane crosslinked polyolefins,  silicone and polyurethane based coatings, adhesives, resins, etc. Because of its special catalytic properties, it brings unique value to these applications.  For example, it is essential in the reaction of polyurethane polymers, accelerating the reaction time and reducing the energy and time needed to fully cure the polymer into a final coating or elastomeric item.  Moreover, the use of DOTL in catalyst applications does not lead to significant exposure to humans or releases to the environment.

Due to the wide use of this substance, any regulatory action or ban on the substance could have significant socio-economic impacts in the EU: 25% of the users are SMEs and substitution (if possible) will affect a lot of products. So, the conversion costs can reach several millions of euros.

There are no suitable alternatives for all applications and the alternatives tested are not sufficiently proven effective in the broad range of applications where DOTL is used.  There is also a inadequate supply to meet the demand.  This means that listing DOTL in the SVHC list will result in difficult substitution and re-formulation, leading to unnecessary changes in technology, and will turn against the EU approach to sustainable development by increasing energy consumption and a larger carbon footprint.
	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.
	
		See the corresponding embedded attachment in table 1 of Part I: 5455_Songwon ECHA public consultation on Dioctyltin dilaurate DOTL.pdf		
5456
2020/10/16	Bomix Chemie GmbH,
Company,
Germany	We would like to thank ECHA for this opportunity to comment on the proposed identification of Dioctyltin dilaurate (DOTL) as a Substance of Very High Concern (SVHC) under REACH.
Bomix Chemie GmbH uses DOTL for the following purposes: Formulation of coatings and release agents for the polyurethane industry.
Potential for human health exposure from our uses is as follows: DOTL is part of our coating and release agent formulations. Both are used during production/moulding of polyurethane parts, like e.g. car steering wheels, engine covers, automotive filters and a whole variety of other technical parts. During the production process of these parts, coatings and release agents are applied by spraying. In general, in the production sites air extraction is mandatory order to strongly reduce/completely avoid exposure of the workers to any chemicals. Therefore, the general exposure of the workers working with our products is strongly reduced. We also see a shift towards automated production strategies. There, quite often no human workforce is directly involved in the production process and exposure of humans to DOTL is fully eliminated. However, while the release agents are just a production aid and are most often cleaned off the surface of the moulded parts, contact with the coating is possible during final assembly of the moulded parts.
Should Authorisation be applied to DOTL, we would estimate the following socioeconomic consequences for our business: Bomix Chemie GmbH is a leading supplier of automotive industry applications like e.g. steering wheel production. Day by day, about 80.000 steering wheels are produced with release agents Bomix Chemie GmbH. Furthermore, a whole variety of mainly other technical parts are produced that are covered with coatings from Bomix Chemie GmbH. The annual turnover with DOTL containing products is about 1,500,000 Euro. The total annual turnover of Bomix Chemie GmbH is about 7,500,000 Euro. Therefore, DOTL containing products are a crucial part of products. In the past, already tremendous effort was undertaken in our R&D departments to find DOTL (and DBTL) alternatives. However, as of today, there is no alternative available.	Thank you for your comment. 

Information regarding use, exposure and alternatives may, where relevant, be considered at later stages of the risk management process.